BETA


2016/2169(DEC) 2015 discharge: European Medicines Agency (EMA)

Progress: Procedure completed

RoleCommitteeRapporteurShadows
Lead CONT AYALA SENDER Inés (icon: S&D S&D) ZDECHOVSKÝ Tomáš (icon: PPE PPE), FITTO Raffaele (icon: ECR ECR), ALI Nedzhmi (icon: ALDE ALDE), JÁVOR Benedek (icon: Verts/ALE Verts/ALE), VALLI Marco (icon: EFDD EFDD), KAPPEL Barbara (icon: ENF ENF)
Committee Opinion ENVI LA VIA Giovanni (icon: PPE PPE) Mireille D'ORNANO (icon: ENF ENF), Julie GIRLING (icon: ECR ECR), Karin KADENBACH (icon: S&D S&D)
Lead committee dossier:

Events

2017/09/29
   Final act published in Official Journal
Details

PURPOSE: to grant discharge to the European Medicines Agency (EMA) for the financial year 2015.

NON-LEGISLATIVE ACT: Decision (EU) 2017/1681 of the European Parliament on discharge in respect of the implementation of the budget of the European Medicines Agency for the financial year 2015.

CONTENT: with this Decision, the European Parliament gives discharge to the Executive Director of the European Medicines Agency for the implementation of the Agency’s budget for 2015.

The Decision is consistent with the European Parliament’s resolution adopted on 27 April 2017 and includes a series of observations that form an integral part of the discharge decision (refer to the summary of the opinion of 27 April 2017).

Amongst Parliament’s main observations in the resolution accompanying the discharge decision, it noted that 2015 marked the 20th anniversary of the Agency and the 50th anniversary of pharmaceutical legislation in the Union. Parliament observed that following the outcome of the UK referendum on 23 June 2016, the Agency established a dedicated task force to focus on relocation preparedness, operational and financial preparedness, HR-related matters and communication (internal and external) aspects.

While welcoming the information provided by the Agency to the discharge authority on its current contractual commitments and liabilities linked to its physical presence in the UK, Parliament noted with concern that the Agency's rental contract until 2039 does not include an early termination clause to release the Agency from the liabilities of rent and associated costs, and that the payable rent for the remaining period from 2017 to 2039 is estimated at EUR 347.6 million. The Agency is asked to report to the discharge authority on any developments on this matter.

The resolution also highlighted that although there had been delays in the collection of fees as noted by the discharge authority, these had no impact on the Agency's and Member States' ability to perform their public health tasks, including pharmacovigilance activities.

Parliament acknowledged from the Agency that the revised policy on the handling of declarations of interests of scientific committees' members and experts entered into force in 2015. The revised policy on handling of declared interests of members of staff of the Agency and candidates before recruitment was finalised in October 2016.

Moreover, an anti-fraud office was established as part of its anti-fraud strategy.

Lastly, Parliament encouraged the Agency to further raise awareness of its conflict-of-interest policy among its staff, alongside ongoing awareness-raising activities and the inclusion of integrity and transparency as obligatory items to be discussed during recruitment procedures and performance reviews.

2017/04/27
   EP - Results of vote in Parliament
2017/04/27
   EP - Decision by Parliament
Details

The European Parliament decided to grant discharge to the Executive Director of the European Medicines Agency (EMA) in respect of the implementation of the budget of Agency for the financial year 2015.

The vote on the decision on discharge covers the closure of the accounts (in accordance with Annex IV, Article 5 (1) (a) to Parliament’s Rules of Procedure).

Noting that the Court of Auditors has stated that it has obtained reasonable assurances that the Agency’s annual accounts for the financial year 2015 are reliable and that the underlying transactions are legal and regular, Parliament adopted by 510 votes to 101 with 13 abstentions, a resolution containing a series of recommendations, which form an integral part of the decision on discharge and which add to the general recommendations set out in the resolution on performance, financial management and control of EU agencies .

These recommendations may be summarised as follows:

Agency’s financial statements : Parliament noted the final budget of the European Medicines Agency for the financial year 2015 was EUR 308 097 000 representing an increase of 9.07 % compared to 2014. Prevention and management of conflicts of interests and transparency : It acknowledged that the revised policy on the handling of declarations of interests of scientific committees’ members and experts entered into force in 2015. Parliament also made a series of observations regarding the budgetary and financial management, commitments and carry-overs, transfers, procurement and recruitment procedures, the prevention and management of conflicts of interests and internal audits and controls.

Communication : Parliament noted that in 2015, the Agency recommended 93 medicines for marketing authorisation and that those include 39 new active substances. It stressed that those substances have previously never been authorised in a medicine in the Union and are not related to the chemical structure of any other authorised substance.

Parliament reminded the Agency that Directive 2003/63/EC states that medicines can only be considered for Union marketing authorisation if they have been tested in accordance with ethical guidelines, and reminded the Agency of its commitment to perform extra checks on clinical trials carried out outside the European Union before granting a drug market authorisation. Therefore, due to the special vulnerabilities of those tests, Parliament asked the Agency to report to the discharge authority every year on actions taken to ensure drugs for the Union market were tested ethically in lower and middle income countries , in accordance with the law.

It underlined that the Agency should continue promoting dialogue with stakeholders and citizens and incorporate it as part of the priorities and activities to be implemented.

Adaptive pathways : Parliament noted that the Agency launched a pilot project on "adaptive pathways" in March 2014 aiming to accelerate market authorisations for specific medicines using the so-called post-marketing authorisation. It is concerned that the pilot project raises numerous public health concerns and undermines the core mission of the Agency, namely to ensure safety of medicines. It asked the Agency to report to the discharge authority on the project and the measures it has taken to ensure that this acceleration of the procedure does not undermine its core mission.

Impact of Brexit : Parliament stated that on 23 June 2016, the citizens of the United Kingdom voted to leave the European Union. It noted that following the outcome of the UK referendum on 23 June 2016, the Agency established a dedicated task force to focus on relocation preparedness, operational and financial preparedness, HR-related matters and communication (internal and external) aspects. It observed that the work currently ongoing is focussed on the impact of a loss of EMA staff in the event of relocation and loss of external expertise due to the potential unavailability of UK expertise in the scientific committees and other EMA fora. An impact assessment including remedial solutions should be available by the end of the first quarter of 2017.

Lastly, Parliament noted with concern that the Agency’s rental contract until 2039 does not include an early termination clause to release the Agency from the liabilities of rent and associated costs, and that the payable rent for the remaining period from 2017 to 2039 is estimated at EUR 347.6 million. It asked the Agency to report to the discharge authority on any developments on this matter.

Documents
2017/04/27
   EP - End of procedure in Parliament
2017/04/26
   EP - Debate in Parliament
2017/03/28
   EP - Committee report tabled for plenary
Details

The Committee on Budgetary Control adopted the report by Inés AYALA SENDER (S&D, ES) on discharge in respect of the implementation of the budget of the European Medicines Agency (EMA) for the financial year 2015.

The committee called on the European Parliament to grant the Executive Director of the Agency discharge in respect of the implementation of the agency’s budget for the financial year 2015.

Noting that the Court of Auditors stated that it had obtained reasonable assurance that the annual accounts of the Agency for the financial year 2015 were reliable and that the underlying transactions were legal and regular, Members called on Parliament to approve the closure of the Agency’s accounts. They made, however, a number of recommendations that needed to be taken into account when the discharge is granted, in addition to the general recommendations that appear in the draft resolution on performance, financial management and control of EU agencies :

Agency’s financial statements : Members note the final budget of the European Medicines Agency for the financial year 2015 was EUR 308 097 000 representing an increase of 9.07 % compared to 2014. Prevention and management of conflicts of interests and transparency : Members acknowledged that the revised policy on the handling of declarations of interests of scientific committees’ members and experts entered into force in 2015. They reminded the Agency that Directive 2003/63/EC states that medicines can only be considered for Union marketing authorisation if they have been tested in accordance with ethical guidelines. They also reminded it of its commitment to perform extra checks on clinical trials carried out outside the European Union before granting a drug market authorisation. The Agency is asked to report to the discharge authority every year on actions taken to ensure drugs for the Union market were tested ethically.

Members also made a series of observations regarding the budgetary and financial management, commitments and carry-overs, transfers, procurement and recruitment procedures, the prevention and management of conflicts of interests and internal audits and controls.

Impact of Brexit : on 23 June 2016, the citizens of the United Kingdom voted to leave the European Union. Members noted that following the outcome of the UK referendum on 23 June 2016, the Agency established a dedicated task force to focus on relocation preparedness, operational and financial preparedness, HR-related matters and communication (internal and external) aspects. They observed that the work currently ongoing is focussed on the impact of a loss of EMA staff in the event of relocation and loss of external expertise due to the potential unavailability of UK expertise in the scientific committees and other EMA fora. An impact assessment including remedial solutions should be available by the end of the first quarter of 2017.

Lastly, Members noted with concern that the Agency’s rental contract until 2039 does not include an early termination clause to release the Agency from the liabilities of rent and associated costs, and that the payable rent for the remaining period from 2017 to 2039 is estimated at EUR 347.6 million. They asked the Agency to report to the discharge authority on any developments on this matter.

Documents
2017/03/22
   EP - Vote in committee
2017/03/06
   EP - Amendments tabled in committee
Documents
2017/02/15
   EP - Committee opinion
Documents
2017/02/07
   CSL - Supplementary non-legislative basic document
Details

Having examined the revenue and expenditure accounts for the financial year 2015 and the balance sheet as at 31 December 2015 of the European Medicines Agency (EMA), as well as the Court of Auditors' report on the annual accounts of the Agency for the financial year 2015, accompanied by the Agency's replies to the Court's observations, the Council recommended the European Parliament to give a discharge to the Executive Director of the Agency in respect of the implementation of the budget for the financial year 2015.

The Council welcomed the Court's opinion that the Agency's annual accounts present fairly its financial position as at 31 December 2015 and the results of its operations and its cash flows for the year then ended, in accordance with the provisions of the Agency's Financial Regulation, and that the underlying transactions for 2015 are legal and regular in all material respects.

Nevertheless, it made one observation:

fees : the Council encouraged the Agency to continue implementing the Court's recommendations from last year as regards the respect of due dates for the collection of fees and the related payments to national competent authorities.

Documents
2017/02/03
   EP - Committee draft report
Documents
2016/10/04
   EP - Committee referral announced in Parliament
2016/09/13
   CofA - Court of Auditors: opinion, report
Details

PURPOSE: presentation of the EU Court of Auditors’ report on the annual accounts of the European Medicines Agency for the financial year 2015, together with the Agency’s reply.

CONTENT: in accordance with the tasks conferred on the Court of Auditors by the Treaty on the Functioning of the European Union, the Court presents to the European Parliament and to the Council, in the context of the discharge procedure, a Statement of Assurance as to the reliability of the annual accounts of each institution, body or agency of the EU, and the legality and regularity of the transactions underlying them, on the basis of an independent external audit.

This audit concerned, amongst others, the annual accounts of the European Medicines Agency (EMA). In brief, the Agency operates through a network and coordinates the scientific resources made available by the national authorities in order to ensure the evaluation and supervision of medicinal products for human or veterinary use.

Statement of assurance : pursuant to the provisions of Article 287 of the Treaty on the Functioning of the European Union (TFEU), the Court has audited:

the annual accounts of the Agency, which comprise the financial statements and the reports on the implementation of the budget for the financial year ended 31 December 2015, and the legality and regularity of the transactions underlying those accounts.

Opinion on the reliability of the accounts : in the Court’s opinion, the Agency’s annual accounts present fairly, in all material respects, its financial position as at 31 December 2015 and the results of its operations and its cash flows for the year then ended, in accordance with the provisions of its Financial Regulation and the accounting rules adopted by the Commission’s accounting officer.

Opinion on the legality and regularity of the transactions underlying the accounts : in the Court’s opinion, the transactions underlying the annual accounts for the year ended 31 December 2015 are legal and regular in all material respects.

The report did not make any particular comments apart from stating that the elements taken into consideration in the report do not take account of the referendum results of 23 June 2016 on the UK vote to leave the EU (and the consequences this may have on the Agency whose headquarters is located in London) as the Court had presented its report before this date.

Lastly, the Court of Auditors’ report contains a summary of the Agency’s key figures in 2015 :

Budget : EUR 304 million. Staff : 775 including officials, temporary and contract staff and seconded national experts.

2016/08/31
   EP - LA VIA Giovanni (PPE) appointed as rapporteur in ENVI
2016/08/05
   EP - AYALA SENDER Inés (S&D) appointed as rapporteur in CONT
2016/07/11
   EC - Non-legislative basic document
Details

PURPOSE: presentation by the Commission of the consolidated annual accounts of the European Union for the financial year 2015, as part of the 2015 discharge procedure.

Analysis of the accounts of the European Medicines Agency (EMA) .

CONTENT: the organisational governance of the EU consists of institutions, agencies and other EU bodies whose expenditure is included in the general budget of the Union.

The EU's operational expenditure of these institutions takes different forms, depending on how the money is paid out and managed.

From 2014 onwards, the Commission classifies its expenditure as follows:

Direct management : the budget is implemented directly by the Commission services. Indirect management : the Commission confers tasks of implementation of the budget to bodies of EU law or national law, such as the EU agencies .

Shared management : under this method of budget implementation tasks are delegated to Member States. About 80 % of the expenditure falls under this management mode covering such areas as agricultural spending and structural actions.

This Commission document concerns the EU's consolidated accounts for the year 2015 and details how spending by the EU institutions and bodies was carried out. The consolidated annual accounts of the EU provide financial information on the activities of the institutions, agencies and other bodies of the EU from an accrual accounting and budgetary perspective.

It is the responsibility of the Commission's Accounting Officer to prepare the EU's consolidated annual accounts and ensure that they present fairly, in all material aspects, the financial position, the result of the operations and the cashflows of the EU institutions and bodies, including the European Medicines Agency (EMA), with a view to granting discharge.

Discharge procedure : the final step of a budget lifecycle is the discharge of the budget for a given financial year. It represents the political aspect of the external control of budget implementation and is the decision by which the European Parliament, acting on a Council recommendation, "releases" the Commission (and other EU bodies) from its responsibility for management of a given budget by marking the end of that budget's existence. The European Parliament is the discharge authority within the EU.

The discharge procedure may produce three outcomes: (i) the granting; (ii) postponement or; (iii) the refusal of the discharge.

The final discharge report including specific recommendations to the Commission for action is adopted in plenary by the European Parliament and are subject to an annual follow up report in which the Commission outlines the concrete actions it has taken to implement the recommendations made.

Each agency is subject to its own discharge procedure, including the European Medicines Agency (EMA).

The European Medicines Agency : the Agency, which is located in London (UK), was created by Council Regulation (EEC) No 2309/93 , which was replaced by Regulation (EC) No 726/2004 of the European Parliament and of the Council and its role is the coordination of the scientific resources made available by the national authorities in order to ensure the evaluation and supervision of medicinal products for human or veterinary use on the basis of a centralised procedure.

As regards Agency’s accounts, these are presented in detail in the document on the consolidated annual accounts of the European Union for 2015:

Commitment appropriations :

- committed : EUR 308 million;

- paid : EUR 290 million;

- carried-over : EUR 6 million.

Payment appropriations:

- committed : EUR 349 million;

- paid : EUR 291 million;

- carried-over : EUR 43 million.

For further details on expenditure, please refer to the final accounts of the EMA .

2016/07/10
   EC - Non-legislative basic document published
Details

PURPOSE: presentation by the Commission of the consolidated annual accounts of the European Union for the financial year 2015, as part of the 2015 discharge procedure.

Analysis of the accounts of the European Medicines Agency (EMA) .

CONTENT: the organisational governance of the EU consists of institutions, agencies and other EU bodies whose expenditure is included in the general budget of the Union.

The EU's operational expenditure of these institutions takes different forms, depending on how the money is paid out and managed.

From 2014 onwards, the Commission classifies its expenditure as follows:

Direct management : the budget is implemented directly by the Commission services. Indirect management : the Commission confers tasks of implementation of the budget to bodies of EU law or national law, such as the EU agencies .

Shared management : under this method of budget implementation tasks are delegated to Member States. About 80 % of the expenditure falls under this management mode covering such areas as agricultural spending and structural actions.

This Commission document concerns the EU's consolidated accounts for the year 2015 and details how spending by the EU institutions and bodies was carried out. The consolidated annual accounts of the EU provide financial information on the activities of the institutions, agencies and other bodies of the EU from an accrual accounting and budgetary perspective.

It is the responsibility of the Commission's Accounting Officer to prepare the EU's consolidated annual accounts and ensure that they present fairly, in all material aspects, the financial position, the result of the operations and the cashflows of the EU institutions and bodies, including the European Medicines Agency (EMA), with a view to granting discharge.

Discharge procedure : the final step of a budget lifecycle is the discharge of the budget for a given financial year. It represents the political aspect of the external control of budget implementation and is the decision by which the European Parliament, acting on a Council recommendation, "releases" the Commission (and other EU bodies) from its responsibility for management of a given budget by marking the end of that budget's existence. The European Parliament is the discharge authority within the EU.

The discharge procedure may produce three outcomes: (i) the granting; (ii) postponement or; (iii) the refusal of the discharge.

The final discharge report including specific recommendations to the Commission for action is adopted in plenary by the European Parliament and are subject to an annual follow up report in which the Commission outlines the concrete actions it has taken to implement the recommendations made.

Each agency is subject to its own discharge procedure, including the European Medicines Agency (EMA).

The European Medicines Agency : the Agency, which is located in London (UK), was created by Council Regulation (EEC) No 2309/93 , which was replaced by Regulation (EC) No 726/2004 of the European Parliament and of the Council and its role is the coordination of the scientific resources made available by the national authorities in order to ensure the evaluation and supervision of medicinal products for human or veterinary use on the basis of a centralised procedure.

As regards Agency’s accounts, these are presented in detail in the document on the consolidated annual accounts of the European Union for 2015:

Commitment appropriations :

- committed : EUR 308 million;

- paid : EUR 290 million;

- carried-over : EUR 6 million.

Payment appropriations:

- committed : EUR 349 million;

- paid : EUR 291 million;

- carried-over : EUR 43 million.

For further details on expenditure, please refer to the final accounts of the EMA .

Documents

Votes

A8-0084/2017 - Inés Ayala Sender - Résolution #

2017/04/27 Outcome: +: 510, -: 101, 0: 13
DE IT ES FR RO PT HU CZ SE BG NL AT BE PL IE LT DK SI FI EL SK CY MT LU HR EE LV GB
Total
75
61
43
56
23
19
19
20
19
16
23
16
20
46
9
8
10
8
11
19
13
6
6
5
7
5
7
53
icon: PPE PPE
192

Denmark PPE

For (1)

1

Cyprus PPE

1

Luxembourg PPE

2

Estonia PPE

For (1)

1
icon: S&D S&D
149

Netherlands S&D

3

Ireland S&D

For (1)

1

Lithuania S&D

1

Slovenia S&D

For (1)

1

Finland S&D

1

Cyprus S&D

2

Malta S&D

3

Luxembourg S&D

For (1)

1

Estonia S&D

For (1)

1

Latvia S&D

1
icon: ALDE ALDE
54

Germany ALDE

2

Romania ALDE

2

Portugal ALDE

1

Austria ALDE

For (1)

1

Ireland ALDE

For (1)

1

Lithuania ALDE

2

Slovenia ALDE

For (1)

1

Luxembourg ALDE

For (1)

1

Croatia ALDE

For (1)

1

Estonia ALDE

2

United Kingdom ALDE

1
icon: Verts/ALE Verts/ALE
47

Italy Verts/ALE

For (1)

1

Hungary Verts/ALE

For (1)

1

Netherlands Verts/ALE

2

Austria Verts/ALE

3

Belgium Verts/ALE

2

Lithuania Verts/ALE

For (1)

1

Denmark Verts/ALE

For (1)

1

Slovenia Verts/ALE

For (1)

1

Finland Verts/ALE

For (1)

1

Luxembourg Verts/ALE

For (1)

1

Croatia Verts/ALE

For (1)

1

Estonia Verts/ALE

For (1)

1

Latvia Verts/ALE

1

United Kingdom Verts/ALE

5
icon: GUE/NGL GUE/NGL
45

Czechia GUE/NGL

2

Sweden GUE/NGL

For (1)

1

Netherlands GUE/NGL

Against (1)

3

Ireland GUE/NGL

3

Denmark GUE/NGL

For (1)

1

Finland GUE/NGL

For (1)

1

Cyprus GUE/NGL

2

United Kingdom GUE/NGL

1
icon: EFDD EFDD
37

Germany EFDD

Against (1)

1

France EFDD

Abstain (1)

1

Czechia EFDD

Against (1)

1

Sweden EFDD

2

Poland EFDD

1
icon: NI NI
14

Germany NI

2

France NI

1

Hungary NI

Abstain (1)

3

Poland NI

Against (1)

1

United Kingdom NI

Against (2)

2
icon: ENF ENF
28
5

Romania ENF

1

Netherlands ENF

3

Belgium ENF

Against (1)

1

Poland ENF

Against (1)

1

United Kingdom ENF

Against (1)

1
icon: ECR ECR
57

Italy ECR

Against (1)

1

Romania ECR

For (1)

1

Czechia ECR

Against (1)

Abstain (1)

2

Bulgaria ECR

Against (1)

1

Netherlands ECR

Against (1)

1

Lithuania ECR

1

Denmark ECR

Against (1)

1

Finland ECR

2

Greece ECR

Against (1)

1

Cyprus ECR

1

Croatia ECR

Against (1)

1

Latvia ECR

Against (1)

1
AmendmentsDossier
46 2016/2169(DEC)
2016/12/14 ENVI 24 amendments...
source: 595.702
2017/03/06 CONT 22 amendments...
source: 599.891

History

(these mark the time of scraping, not the official date of the change)

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  • date: 2016-07-11T00:00:00 docs: url: http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2016&nu_doc=0475 title: COM(2016)0475 type: Non-legislative basic document published celexid: CELEX:52016DC0475:EN body: EC commission: DG: url: http://ec.europa.eu/info/departments/budget_en title: Budget Commissioner: GEORGIEVA Kristalina type: Non-legislative basic document published
  • date: 2016-10-04T00:00:00 body: EP type: Committee referral announced in Parliament, 1st reading/single reading committees: body: EP shadows: group: EPP name: ZDECHOVSKÝ Tomáš group: ECR name: FITTO Raffaele group: ALDE name: ALI Nedzhmi group: GUE/NGL name: DE JONG Dennis group: Verts/ALE name: JÁVOR Benedek group: EFD name: VALLI Marco group: ENF name: KAPPEL Barbara responsible: True committee: CONT date: 2016-08-05T00:00:00 committee_full: Budgetary Control rapporteur: group: S&D name: AYALA SENDER Inés body: EP responsible: False committee: ENVI date: 2016-08-31T00:00:00 committee_full: Environment, Public Health and Food Safety rapporteur: group: EPP name: LA VIA Giovanni
  • date: 2017-03-22T00:00:00 body: EP type: Vote in committee, 1st reading/single reading committees: body: EP shadows: group: EPP name: ZDECHOVSKÝ Tomáš group: ECR name: FITTO Raffaele group: ALDE name: ALI Nedzhmi group: GUE/NGL name: DE JONG Dennis group: Verts/ALE name: JÁVOR Benedek group: EFD name: VALLI Marco group: ENF name: KAPPEL Barbara responsible: True committee: CONT date: 2016-08-05T00:00:00 committee_full: Budgetary Control rapporteur: group: S&D name: AYALA SENDER Inés body: EP responsible: False committee: ENVI date: 2016-08-31T00:00:00 committee_full: Environment, Public Health and Food Safety rapporteur: group: EPP name: LA VIA Giovanni
  • date: 2017-03-28T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A8-2017-0084&language=EN type: Committee report tabled for plenary, single reading title: A8-0084/2017 body: EP type: Committee report tabled for plenary, single reading
  • date: 2017-04-26T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?secondRef=TOC&language=EN&reference=20170426&type=CRE type: Debate in Parliament title: Debate in Parliament body: EP type: Debate in Parliament
  • date: 2017-04-27T00:00:00 docs: url: http://www.europarl.europa.eu/oeil/popups/sda.do?id=29303&l=en type: Results of vote in Parliament title: Results of vote in Parliament url: http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P8-TA-2017-0172 type: Decision by Parliament, 1st reading/single reading title: T8-0172/2017 body: EP type: Results of vote in Parliament
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  • date: 2016-09-13T00:00:00 docs: url: https://eur-lex.europa.eu/legal-content/FR/TXT/?uri=OJ:C:2016:449:TOC title: OJ C 449 01.12.2016, p. 0123 title: N8-0124/2016 summary: PURPOSE: presentation of the EU Court of Auditors’ report on the annual accounts of the European Medicines Agency for the financial year 2015, together with the Agency’s reply. CONTENT: in accordance with the tasks conferred on the Court of Auditors by the Treaty on the Functioning of the European Union, the Court presents to the European Parliament and to the Council, in the context of the discharge procedure, a Statement of Assurance as to the reliability of the annual accounts of each institution, body or agency of the EU, and the legality and regularity of the transactions underlying them, on the basis of an independent external audit. This audit concerned, amongst others, the annual accounts of the European Medicines Agency (EMA). In brief, the Agency operates through a network and coordinates the scientific resources made available by the national authorities in order to ensure the evaluation and supervision of medicinal products for human or veterinary use. Statement of assurance : pursuant to the provisions of Article 287 of the Treaty on the Functioning of the European Union (TFEU), the Court has audited: the annual accounts of the Agency, which comprise the financial statements and the reports on the implementation of the budget for the financial year ended 31 December 2015, and the legality and regularity of the transactions underlying those accounts. Opinion on the reliability of the accounts : in the Court’s opinion, the Agency’s annual accounts present fairly, in all material respects, its financial position as at 31 December 2015 and the results of its operations and its cash flows for the year then ended, in accordance with the provisions of its Financial Regulation and the accounting rules adopted by the Commission’s accounting officer. Opinion on the legality and regularity of the transactions underlying the accounts : in the Court’s opinion, the transactions underlying the annual accounts for the year ended 31 December 2015 are legal and regular in all material respects. The report did not make any particular comments apart from stating that the elements taken into consideration in the report do not take account of the referendum results of 23 June 2016 on the UK vote to leave the EU (and the consequences this may have on the Agency whose headquarters is located in London) as the Court had presented its report before this date. Lastly, the Court of Auditors’ report contains a summary of the Agency’s key figures in 2015 : Budget : EUR 304 million. Staff : 775 including officials, temporary and contract staff and seconded national experts. type: Court of Auditors: opinion, report body: CofA
  • date: 2017-02-03T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE593.883 title: PE593.883 type: Committee draft report body: EP
  • date: 2017-02-07T00:00:00 docs: url: http://register.consilium.europa.eu/content/out?lang=EN&typ=SET&i=ADV&RESULTSET=1&DOC_ID=5873%2F17&DOC_LANCD=EN&ROWSPP=25&NRROWS=500&ORDERBY=DOC_DATE+DESC title: 05873/2017 summary: Having examined the revenue and expenditure accounts for the financial year 2015 and the balance sheet as at 31 December 2015 of the European Medicines Agency (EMA), as well as the Court of Auditors' report on the annual accounts of the Agency for the financial year 2015, accompanied by the Agency's replies to the Court's observations, the Council recommended the European Parliament to give a discharge to the Executive Director of the Agency in respect of the implementation of the budget for the financial year 2015. The Council welcomed the Court's opinion that the Agency's annual accounts present fairly its financial position as at 31 December 2015 and the results of its operations and its cash flows for the year then ended, in accordance with the provisions of the Agency's Financial Regulation, and that the underlying transactions for 2015 are legal and regular in all material respects. Nevertheless, it made one observation: fees : the Council encouraged the Agency to continue implementing the Court's recommendations from last year as regards the respect of due dates for the collection of fees and the related payments to national competent authorities. type: Supplementary non-legislative basic document body: CSL
  • date: 2017-02-15T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE592.296&secondRef=05 title: PE592.296 committee: ENVI type: Committee opinion body: EP
  • date: 2017-03-06T00:00:00 docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE599.891 title: PE599.891 type: Amendments tabled in committee body: EP
events
  • date: 2016-07-11T00:00:00 type: Non-legislative basic document published body: EC docs: url: https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2016&nu_doc=0475 title: EUR-Lex title: COM(2016)0475 summary: PURPOSE: presentation by the Commission of the consolidated annual accounts of the European Union for the financial year 2015, as part of the 2015 discharge procedure. Analysis of the accounts of the European Medicines Agency (EMA) . CONTENT: the organisational governance of the EU consists of institutions, agencies and other EU bodies whose expenditure is included in the general budget of the Union. The EU's operational expenditure of these institutions takes different forms, depending on how the money is paid out and managed. From 2014 onwards, the Commission classifies its expenditure as follows: Direct management : the budget is implemented directly by the Commission services. Indirect management : the Commission confers tasks of implementation of the budget to bodies of EU law or national law, such as the EU agencies . Shared management : under this method of budget implementation tasks are delegated to Member States. About 80 % of the expenditure falls under this management mode covering such areas as agricultural spending and structural actions. This Commission document concerns the EU's consolidated accounts for the year 2015 and details how spending by the EU institutions and bodies was carried out. The consolidated annual accounts of the EU provide financial information on the activities of the institutions, agencies and other bodies of the EU from an accrual accounting and budgetary perspective. It is the responsibility of the Commission's Accounting Officer to prepare the EU's consolidated annual accounts and ensure that they present fairly, in all material aspects, the financial position, the result of the operations and the cashflows of the EU institutions and bodies, including the European Medicines Agency (EMA), with a view to granting discharge. Discharge procedure : the final step of a budget lifecycle is the discharge of the budget for a given financial year. It represents the political aspect of the external control of budget implementation and is the decision by which the European Parliament, acting on a Council recommendation, "releases" the Commission (and other EU bodies) from its responsibility for management of a given budget by marking the end of that budget's existence. The European Parliament is the discharge authority within the EU. The discharge procedure may produce three outcomes: (i) the granting; (ii) postponement or; (iii) the refusal of the discharge. The final discharge report including specific recommendations to the Commission for action is adopted in plenary by the European Parliament and are subject to an annual follow up report in which the Commission outlines the concrete actions it has taken to implement the recommendations made. Each agency is subject to its own discharge procedure, including the European Medicines Agency (EMA). The European Medicines Agency : the Agency, which is located in London (UK), was created by Council Regulation (EEC) No 2309/93 , which was replaced by Regulation (EC) No 726/2004 of the European Parliament and of the Council and its role is the coordination of the scientific resources made available by the national authorities in order to ensure the evaluation and supervision of medicinal products for human or veterinary use on the basis of a centralised procedure. As regards Agency’s accounts, these are presented in detail in the document on the consolidated annual accounts of the European Union for 2015: Commitment appropriations : - committed : EUR 308 million; - paid : EUR 290 million; - carried-over : EUR 6 million. Payment appropriations: - committed : EUR 349 million; - paid : EUR 291 million; - carried-over : EUR 43 million. For further details on expenditure, please refer to the final accounts of the EMA .
  • date: 2016-10-04T00:00:00 type: Committee referral announced in Parliament, 1st reading/single reading body: EP
  • date: 2017-03-22T00:00:00 type: Vote in committee, 1st reading/single reading body: EP
  • date: 2017-03-28T00:00:00 type: Committee report tabled for plenary, single reading body: EP docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A8-2017-0084&language=EN title: A8-0084/2017 summary: The Committee on Budgetary Control adopted the report by Inés AYALA SENDER (S&D, ES) on discharge in respect of the implementation of the budget of the European Medicines Agency (EMA) for the financial year 2015. The committee called on the European Parliament to grant the Executive Director of the Agency discharge in respect of the implementation of the agency’s budget for the financial year 2015. Noting that the Court of Auditors stated that it had obtained reasonable assurance that the annual accounts of the Agency for the financial year 2015 were reliable and that the underlying transactions were legal and regular, Members called on Parliament to approve the closure of the Agency’s accounts. They made, however, a number of recommendations that needed to be taken into account when the discharge is granted, in addition to the general recommendations that appear in the draft resolution on performance, financial management and control of EU agencies : Agency’s financial statements : Members note the final budget of the European Medicines Agency for the financial year 2015 was EUR 308 097 000 representing an increase of 9.07 % compared to 2014. Prevention and management of conflicts of interests and transparency : Members acknowledged that the revised policy on the handling of declarations of interests of scientific committees’ members and experts entered into force in 2015. They reminded the Agency that Directive 2003/63/EC states that medicines can only be considered for Union marketing authorisation if they have been tested in accordance with ethical guidelines. They also reminded it of its commitment to perform extra checks on clinical trials carried out outside the European Union before granting a drug market authorisation. The Agency is asked to report to the discharge authority every year on actions taken to ensure drugs for the Union market were tested ethically. Members also made a series of observations regarding the budgetary and financial management, commitments and carry-overs, transfers, procurement and recruitment procedures, the prevention and management of conflicts of interests and internal audits and controls. Impact of Brexit : on 23 June 2016, the citizens of the United Kingdom voted to leave the European Union. Members noted that following the outcome of the UK referendum on 23 June 2016, the Agency established a dedicated task force to focus on relocation preparedness, operational and financial preparedness, HR-related matters and communication (internal and external) aspects. They observed that the work currently ongoing is focussed on the impact of a loss of EMA staff in the event of relocation and loss of external expertise due to the potential unavailability of UK expertise in the scientific committees and other EMA fora. An impact assessment including remedial solutions should be available by the end of the first quarter of 2017. Lastly, Members noted with concern that the Agency’s rental contract until 2039 does not include an early termination clause to release the Agency from the liabilities of rent and associated costs, and that the payable rent for the remaining period from 2017 to 2039 is estimated at EUR 347.6 million. They asked the Agency to report to the discharge authority on any developments on this matter.
  • date: 2017-04-26T00:00:00 type: Debate in Parliament body: EP docs: url: http://www.europarl.europa.eu/sides/getDoc.do?secondRef=TOC&language=EN&reference=20170426&type=CRE title: Debate in Parliament
  • date: 2017-04-27T00:00:00 type: Results of vote in Parliament body: EP docs: url: https://oeil.secure.europarl.europa.eu/oeil/popups/sda.do?id=29303&l=en title: Results of vote in Parliament
  • date: 2017-04-27T00:00:00 type: Decision by Parliament, 1st reading/single reading body: EP docs: url: http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P8-TA-2017-0172 title: T8-0172/2017 summary: The European Parliament decided to grant discharge to the Executive Director of the European Medicines Agency (EMA) in respect of the implementation of the budget of Agency for the financial year 2015. The vote on the decision on discharge covers the closure of the accounts (in accordance with Annex IV, Article 5 (1) (a) to Parliament’s Rules of Procedure). Noting that the Court of Auditors has stated that it has obtained reasonable assurances that the Agency’s annual accounts for the financial year 2015 are reliable and that the underlying transactions are legal and regular, Parliament adopted by 510 votes to 101 with 13 abstentions, a resolution containing a series of recommendations, which form an integral part of the decision on discharge and which add to the general recommendations set out in the resolution on performance, financial management and control of EU agencies . These recommendations may be summarised as follows: Agency’s financial statements : Parliament noted the final budget of the European Medicines Agency for the financial year 2015 was EUR 308 097 000 representing an increase of 9.07 % compared to 2014. Prevention and management of conflicts of interests and transparency : It acknowledged that the revised policy on the handling of declarations of interests of scientific committees’ members and experts entered into force in 2015. Parliament also made a series of observations regarding the budgetary and financial management, commitments and carry-overs, transfers, procurement and recruitment procedures, the prevention and management of conflicts of interests and internal audits and controls. Communication : Parliament noted that in 2015, the Agency recommended 93 medicines for marketing authorisation and that those include 39 new active substances. It stressed that those substances have previously never been authorised in a medicine in the Union and are not related to the chemical structure of any other authorised substance. Parliament reminded the Agency that Directive 2003/63/EC states that medicines can only be considered for Union marketing authorisation if they have been tested in accordance with ethical guidelines, and reminded the Agency of its commitment to perform extra checks on clinical trials carried out outside the European Union before granting a drug market authorisation. Therefore, due to the special vulnerabilities of those tests, Parliament asked the Agency to report to the discharge authority every year on actions taken to ensure drugs for the Union market were tested ethically in lower and middle income countries , in accordance with the law. It underlined that the Agency should continue promoting dialogue with stakeholders and citizens and incorporate it as part of the priorities and activities to be implemented. Adaptive pathways : Parliament noted that the Agency launched a pilot project on "adaptive pathways" in March 2014 aiming to accelerate market authorisations for specific medicines using the so-called post-marketing authorisation. It is concerned that the pilot project raises numerous public health concerns and undermines the core mission of the Agency, namely to ensure safety of medicines. It asked the Agency to report to the discharge authority on the project and the measures it has taken to ensure that this acceleration of the procedure does not undermine its core mission. Impact of Brexit : Parliament stated that on 23 June 2016, the citizens of the United Kingdom voted to leave the European Union. It noted that following the outcome of the UK referendum on 23 June 2016, the Agency established a dedicated task force to focus on relocation preparedness, operational and financial preparedness, HR-related matters and communication (internal and external) aspects. It observed that the work currently ongoing is focussed on the impact of a loss of EMA staff in the event of relocation and loss of external expertise due to the potential unavailability of UK expertise in the scientific committees and other EMA fora. An impact assessment including remedial solutions should be available by the end of the first quarter of 2017. Lastly, Parliament noted with concern that the Agency’s rental contract until 2039 does not include an early termination clause to release the Agency from the liabilities of rent and associated costs, and that the payable rent for the remaining period from 2017 to 2039 is estimated at EUR 347.6 million. It asked the Agency to report to the discharge authority on any developments on this matter.
  • date: 2017-04-27T00:00:00 type: End of procedure in Parliament body: EP
  • date: 2017-09-29T00:00:00 type: Final act published in Official Journal summary: PURPOSE: to grant discharge to the European Medicines Agency (EMA) for the financial year 2015. NON-LEGISLATIVE ACT: Decision (EU) 2017/1681 of the European Parliament on discharge in respect of the implementation of the budget of the European Medicines Agency for the financial year 2015. CONTENT: with this Decision, the European Parliament gives discharge to the Executive Director of the European Medicines Agency for the implementation of the Agency’s budget for 2015. The Decision is consistent with the European Parliament’s resolution adopted on 27 April 2017 and includes a series of observations that form an integral part of the discharge decision (refer to the summary of the opinion of 27 April 2017). Amongst Parliament’s main observations in the resolution accompanying the discharge decision, it noted that 2015 marked the 20th anniversary of the Agency and the 50th anniversary of pharmaceutical legislation in the Union. Parliament observed that following the outcome of the UK referendum on 23 June 2016, the Agency established a dedicated task force to focus on relocation preparedness, operational and financial preparedness, HR-related matters and communication (internal and external) aspects. While welcoming the information provided by the Agency to the discharge authority on its current contractual commitments and liabilities linked to its physical presence in the UK, Parliament noted with concern that the Agency's rental contract until 2039 does not include an early termination clause to release the Agency from the liabilities of rent and associated costs, and that the payable rent for the remaining period from 2017 to 2039 is estimated at EUR 347.6 million. The Agency is asked to report to the discharge authority on any developments on this matter. The resolution also highlighted that although there had been delays in the collection of fees as noted by the discharge authority, these had no impact on the Agency's and Member States' ability to perform their public health tasks, including pharmacovigilance activities. Parliament acknowledged from the Agency that the revised policy on the handling of declarations of interests of scientific committees' members and experts entered into force in 2015. The revised policy on handling of declared interests of members of staff of the Agency and candidates before recruitment was finalised in October 2016. Moreover, an anti-fraud office was established as part of its anti-fraud strategy. Lastly, Parliament encouraged the Agency to further raise awareness of its conflict-of-interest policy among its staff, alongside ongoing awareness-raising activities and the inclusion of integrity and transparency as obligatory items to be discussed during recruitment procedures and performance reviews.
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  • The European Parliament decided to grant discharge to the Executive Director of the European Medicines Agency (EMA) in respect of the implementation of the budget of Agency for the financial year 2015.

    The vote on the decision on discharge covers the closure of the accounts (in accordance with Annex IV, Article 5 (1) (a) to Parliament’s Rules of Procedure).

    Noting that the Court of Auditors has stated that it has obtained reasonable assurances that the Agency’s annual accounts for the financial year 2015 are reliable and that the underlying transactions are legal and regular, Parliament adopted by 510 votes to 101 with 13 abstentions, a resolution containing a series of recommendations, which form an integral part of the decision on discharge and which add to the general recommendations set out in the resolution on performance, financial management and control of EU agencies.

    These recommendations may be summarised as follows:

    • Agency’s financial statements: Parliament noted the final budget of the European Medicines Agency for the financial year 2015 was EUR 308 097 000 representing an increase of 9.07 % compared to 2014.
    • Prevention and management of conflicts of interests and transparency: It acknowledged that the revised policy on the handling of declarations of interests of scientific committees’ members and experts entered into force in 2015. Parliament also made a series of observations regarding the budgetary and financial management, commitments and carry-overs, transfers, procurement and recruitment procedures, the prevention and management of conflicts of interests and internal audits and controls.

    Communication: Parliament noted that in 2015, the Agency recommended 93 medicines for marketing authorisation and that those include 39 new active substances. It stressed that those substances have previously never been authorised in a medicine in the Union and are not related to the chemical structure of any other authorised substance.

    Parliament reminded the Agency that Directive 2003/63/EC states that medicines can only be considered for Union marketing authorisation if they have been tested in accordance with ethical guidelines, and reminded the Agency of its commitment to perform extra checks on clinical trials carried out outside the European Union before granting a drug market authorisation. Therefore, due to the special vulnerabilities of those tests, Parliament asked the Agency to report to the discharge authority every year on actions taken to ensure drugs for the Union market were tested ethically in lower and middle income countries, in accordance with the law.

    It underlined that the Agency should continue promoting dialogue with stakeholders and citizens and incorporate it as part of the priorities and activities to be implemented.

    Adaptive pathways: Parliament noted that the Agency launched a pilot project on "adaptive pathways" in March 2014 aiming to accelerate market authorisations for specific medicines using the so-called post-marketing authorisation. It is concerned that the pilot project raises numerous public health concerns and undermines the core mission of the Agency, namely to ensure safety of medicines. It asked the Agency to report to the discharge authority on the project and the measures it has taken to ensure that this acceleration of the procedure does not undermine its core mission.

    Impact of Brexit: Parliament stated that on 23 June 2016, the citizens of the United Kingdom voted to leave the European Union. It noted that following the outcome of the UK referendum on 23 June 2016, the Agency established a dedicated task force to focus on relocation preparedness, operational and financial preparedness, HR-related matters and communication (internal and external) aspects. It observed that the work currently ongoing is focussed on the impact of a loss of EMA staff in the event of relocation and loss of external expertise due to the potential unavailability of UK expertise in the scientific committees and other EMA fora. An impact assessment including remedial solutions should be available by the end of the first quarter of 2017.

    Lastly, Parliament noted with concern that the Agency’s rental contract until 2039 does not include an early termination clause to release the Agency from the liabilities of rent and associated costs, and that the payable rent for the remaining period from 2017 to 2039 is estimated at EUR 347.6 million. It asked the Agency to report to the discharge authority on any developments on this matter.

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  • The Committee on Budgetary Control adopted the report by Inés AYALA SENDER (S&D, ES) on discharge in respect of the implementation of the budget of the European Medicines Agency (EMA) for the financial year 2015.

    The committee called on the European Parliament to grant the Executive Director of the Agency discharge in respect of the implementation of the agency’s budget for the financial year 2015.

    Noting that the Court of Auditors stated that it had obtained reasonable assurance that the annual accounts of the Agency for the financial year 2015 were reliable and that the underlying transactions were legal and regular, Members called on Parliament to approve the closure of the Agency’s accounts. They made, however, a number of recommendations that needed to be taken into account when the discharge is granted, in addition to the general recommendations that appear in the draft resolution on performance, financial management and control of EU agencies:

    • Agency’s financial statements: Members note the final budget of the European Medicines Agency for the financial year 2015 was EUR 308 097 000 representing an increase of 9.07 % compared to 2014.
    • Prevention and management of conflicts of interests and transparency: Members acknowledged that the revised policy on the handling of declarations of interests of scientific committees’ members and experts entered into force in 2015. They reminded the Agency that Directive 2003/63/EC states that medicines can only be considered for Union marketing authorisation if they have been tested in accordance with ethical guidelines. They also reminded it of its commitment to perform extra checks on clinical trials carried out outside the European Union before granting a drug market authorisation. The Agency is asked to report to the discharge authority every year on actions taken to ensure drugs for the Union market were tested ethically.

    Members also made a series of observations regarding the budgetary and financial management, commitments and carry-overs, transfers, procurement and recruitment procedures, the prevention and management of conflicts of interests and internal audits and controls.

    Impact of Brexit: on 23 June 2016, the citizens of the United Kingdom voted to leave the European Union. Members noted that following the outcome of the UK referendum on 23 June 2016, the Agency established a dedicated task force to focus on relocation preparedness, operational and financial preparedness, HR-related matters and communication (internal and external) aspects. They observed that the work currently ongoing is focussed on the impact of a loss of EMA staff in the event of relocation and loss of external expertise due to the potential unavailability of UK expertise in the scientific committees and other EMA fora. An impact assessment including remedial solutions should be available by the end of the first quarter of 2017.

    Lastly, Members noted with concern that the Agency’s rental contract until 2039 does not include an early termination clause to release the Agency from the liabilities of rent and associated costs, and that the payable rent for the remaining period from 2017 to 2039 is estimated at EUR 347.6 million. They asked the Agency to report to the discharge authority on any developments on this matter.

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  • PURPOSE: presentation by the Commission of the consolidated annual accounts of the European Union for the financial year 2015, as part of the 2015 discharge procedure.

    Analysis of the accounts of the European Medicines Agency (EMA).

    CONTENT: the organisational governance of the EU consists of institutions, agencies and other EU bodies whose expenditure is included in the general budget of the Union.

    The EU's operational expenditure of these institutions takes different forms, depending on how the money is paid out and managed.

    From 2014 onwards, the Commission classifies its expenditure as follows:

    • Direct management: the budget is implemented directly by the Commission services.
    • Indirect management: the Commission confers tasks of implementation of the budget to bodies of EU law or national law, such as the EU agencies.
    • Shared management: under this method of budget implementation tasks are delegated to Member States. About 80 % of the expenditure falls under this management mode covering such areas as agricultural spending and structural actions.

    This Commission document concerns the EU's consolidated accounts for the year 2015 and details how spending by the EU institutions and bodies was carried out. The consolidated annual accounts of the EU provide financial information on the activities of the institutions, agencies and other bodies of the EU from an accrual accounting and budgetary perspective.

    It is the responsibility of the Commission's Accounting Officer to prepare the EU's consolidated annual accounts and ensure that they present fairly, in all material aspects, the financial position, the result of the operations and the cashflows of the EU institutions and bodies, including the European Medicines Agency (EMA), with a view to granting discharge.

    Discharge procedure: the final step of a budget lifecycle is the discharge of the budget for a given financial year. It represents the political aspect of the external control of budget implementation and is the decision by which the European Parliament, acting on a Council recommendation, "releases" the Commission (and other EU bodies) from its responsibility for management of a given budget by marking the end of that budget's existence. The European Parliament is the discharge authority within the EU.

    The discharge procedure may produce three outcomes: (i) the granting; (ii) postponement or; (iii) the refusal of the discharge.

    The final discharge report including specific recommendations to the Commission for action is adopted in plenary by the European Parliament and are subject to an annual follow up report in which the Commission outlines the concrete actions it has taken to implement the recommendations made.

    Each agency is subject to its own discharge procedure, including the European Medicines Agency (EMA).

    The European Medicines Agency: the Agency, which is located in London (UK), was created by Council Regulation (EEC) No 2309/93, which was replaced by Regulation (EC) No 726/2004 of the European Parliament and of the Council and its role is the coordination of the scientific resources made available by the national authorities in order to ensure the evaluation and supervision of medicinal products for human or veterinary use on the basis of a centralised procedure.

    As regards Agency’s accounts, these are presented in detail in the document on the consolidated annual accounts of the European Union for 2015:

    Commitment appropriations:

    -          committed: EUR 308 million;

    -          paid: EUR 290 million;

    -          carried-over: EUR 6 million.

    Payment appropriations:

    -          committed: EUR 349 million;

    -          paid: EUR 291 million;

    -          carried-over: EUR 43 million.

    For further details on expenditure, please refer to the final accounts of the EMA.

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